One among thousands of reasons to be frightened by the prospect of a Warren presidency: she would spearhead a populist shakedown of pharma and biotech companies.

From CNS News:

Sen. Elizabeth Warren (D-Mass.) touted increasing spending in public medical research at a Families USA Health Action Conference at the Hyatt hotel in Washington, D.C., on Thursday telling drug companies you “did not do it alone” and “we built those medical innovations together.”

“We celebrate the accomplishments of our pharmaceutical industry because these blockbuster drugs let people live longer, healthier lives,” Warren said. “But we are also mindful that these drug companies did not do it alone.

“Many drugs have generated billion-dollar profits and are used by millions of consumers that don’t just appear overnight,” Warren said. “Rarely do they appear as a result of a single giant company’s individual genius.

“Drug companies make great contributions, but so do taxpayers,” Warren said. “In other words, we built those medical innovations together.”

Celldex is growing and expanding, and new positions continue to be added. Management must be confident that there will be ample revenue to justify the additional personnel and operational costs associated with ramping up (commercial) production and increasing clinical investigations of treatments deep in the pipeline.

Management is conducting business as if early approval of Rindo is a fait accompli.

Here is how I understand it: if ordinary taxable income remains within the 10% or the 15% tax bracket, then LTCG income added to ordinary taxable income up to the point of crossing out of the 15% bracket will be assessed 0% LTCG tax; any LTCG added beyond that level will be assessed 15% LTCG tax (followed by 20% for those with very large gains).

So, if you realize more than $73k in ordinary taxable income (as a married couple) you cannot enjoy the 0% LTCG rate on any realized LTCG. If you realize less than $73k in ordinary taxable income, you can enjoy the 0% LTCG rate on realized LTCG up to the point of reaching $73k in total of both ordinary and LTCG income; above that amount you pay 15% (or 20%) on additional LTCG income.

The endpoint that matters is PFS6, so the longest wait time would be six months following the final patient's commencement of treatment. Marucci stated in November that there were four remaining patients in the study to evaluate for PFS6, and he estimated that the final data would be available in 2-6 months. If all four of those patients progress in disease sooner than six months then the wait time will be less; in that case the study could possibly have been completed by now. If at least one of the patients does not progress for six months then the wait time will be until at least April or May. We do not know how many of the four remaining patients received Rindo versus control treatment. Presumably, according to the data thus far, the control patients will progress in disease more quickly than Rindo patients.

"Leftist ideologue" is a redundant expression. Leftism is divorced from reason and real experience, hence it can only be held as a worldview by a strong exercise of a sheer will to believe and a simultaneous will to disregard any fact or argument that would contradict it. Leftism is immature voluntas: believing the world can become what you wish it to be.

Remember too that in the original version of this job listing the description added "Rindopepimut in glioblastoma multiforme" as an appositive after the words, "for the company's inaugural product." Management is certain that Rindo will be approved this year as its inaugural product, although since it is not a material fact that Rindo will be Celldex's inaugural product it was prudent to remove that detail from the job listing.

You are the guy who asks ignorant questions about CLDX. For your information, the METRIC study is a pivotal trial, meaning Celldex management has already secured the FDA's agreement that if the study meets the endpoints then Glemba will be granted accelerated approval. For your further information, management announced in November that it had modified the trial's protocol in part to open up the possibility that a successful trial could also be the basis for approval in the EU.

The takedown of the share price from $21.48 early this morning was all about harvesting stops. Now the share price is back up at the high reached nearly out of the gate. Anyone who was stopped out is missing out on the gains.

Remove all trailing stops from your CLDX shares if you wish to reap the benefits of being long. Attempting to protect profits by having a trailing stop of even $2 will result in you missing out on additional larger gains.

The pros want your CLDX shares, and they will use every legal trick in the book to acquire them from you.

You're wrong: the phase 3 trial, which is called ACT-IV, might not even have reached the interim analysis triggered by 50% of events/deaths by May. Management has projected that that threshold should be reached by mid-2015. Only after that interim has been reached will management be able to provide updated guidance about when the trial will be expected to conclude.

Of course, if the data are superb and statistically significant then ACT-IV could be stopped early for efficacy at the first interim analysis. The superb results from ReACT and the delay in reaching 50% of deaths both lend support to the hypothesis that ACT-IV patients who are being treated with Rindo are doing well and living longer than originally expected.

They had to short intensely to avoid the share price running away from them. It almost got away from them when only about 50k shares took it from $21 to $21.48 in a heartbeat. Since then it's been walked and held down firmly.

That would make sense because the commercial manufacturing process has to meet FDA guidelines just as it does for manufacturing drugs for clinical trials. It might have to do with scaling from clinical trials production (small quantities) to commercial production (large quantities). The FDA wants assurance that commercial production meets the same standards and quality as was present during production for clinical trials.

A chemical, manufacturing and control (CMC) section is a component of a submission for regulatory approval. It is not merely a pre-clinical consideration, as you state. It directly concerns applications for approval of new treatments. Refer to the following excerpt from a recent news story about an unrelated company and treatment for evidence of the importance of CMC in filing regulatory submissions.

Also in the story below, note how quickly a treatment can be made available for commercial sale following approval. Rintega could be available for commercial sale this year.

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IPXL shares jumped 11.7% and attained a 52-week high on the FDA approval of Rytary, an extended-release oral capsule formulation of carbidopa-levodopa. The FDA has approved Rytary for the treatment of patients suffering from Parkinson's disease and post-encephalitic parkinsonism, and parkinsonism that may follow carbon monoxide intoxication and / or manganese intoxication.

We note that Rytary's approval path has not exactly been smooth with the company receiving a complete response letter for the drug in Jan 2013. The new drug application (NDA) was resubmitted by Impax in Apr 2014. However, the initial FDA action date of Oct 2014 was pushed out to Jan 2015 due to an amendment in the chemical, manufacturing and control (CMC) section of the resubmitted NDA.

Rytary will be available for commercial distribution in Feb 2015 and Impax is currently seeking EU approval for the drug.

Celldex is looking for a candidate to manage regulatory CMC aspects of Celldex's therapeutic development programs, in collaboration with regulatory product leaders. Responsibility includes authoring and reviewing CMC sections in regulatory submissions. This person will also manage regulatory submissions and applications for clinical trials, agency meetings, annual reports, and maintenance required for INDs and CTAs.

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